510(k) · Cleared
ClearedTriton Sponge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gauss Surgical, Inc., · PBZ Image Processing Device For Estimation Of External Blood Loss
Cleared on Apr 25, 2017 as substantially equivalent to K160338 (Gauss Surgical, Inc.,, 2016) after a 132-day review. Its family tree reaches back 2 generations to 2014. 2 later devices descend from it.
- Decided
- Apr 25, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- PBZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130015 (2014). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN130015 Pixel 3 SystemGauss Surgical, Inc., · 2014
- 1 generation backK160338 Triton SystemGauss Surgical, Inc., · 2016
- This deviceK163507 Triton Sponge SystemGauss Surgical, Inc., · 2017
- Descendant · cites it directly · 1 of its ownK232250 SurgiCount+ SystemStryker Instruments · 2024
- Descendant · 2 generations on · 0 of its ownK252282 SurgiCount+ SystemStryker Instruments · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN130015 | Pixel 3 System | Gauss Surgical, Inc., | 2014 | — |
| −1 | K160338 | Triton System | Gauss Surgical, Inc., | 2016 | — |
| 0 (this device) | K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017 | — |
| +1 | K232250 | SurgiCount+ System | Stryker Instruments | 2024 | — |
| +2 | K252282 | SurgiCount+ System | Stryker Instruments | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBZ device
- #1 K252282 SurgiCount+ Systemscore 11.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160338 | Triton SystemSummary page 4…(21 CFR §880.2750) Product Code: PBZ III. PREDICATE DEVICE INFORMATION Equivalent Devices: Triton System K160338, August 5, 2016. This predicate device has not been subject to a recall. No reference devices were… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232250 | SurgiCount+ System | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232250 (Stryker Instruments, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PBZ devicesPBZ Image Processing Device For Estimation Of External Blood Loss: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PBZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PBZ
Too few PBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBZ
No recall names PBZ since 2007.
Adverse event reports per year · PBZ
6in 2025
MAUDE reports naming product code PBZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 246 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Triton Sponge System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton Sponge System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with the Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton Sponge System is also intended to calculate…
Read the full statement (188 words)
The Triton Sponge System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges. The Triton Sponge System is intended to be used with surgical sponges, software, hardware and accessory devices which have been validated for use with the Triton Sponge System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton Sponge System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use. The Triton Sponge System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton Sponge System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163507: Triton Sponge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163507
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026